DyslipidemiasPhase 4NCT03906539

Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia

A Phase 4 study testing Atorvastatin 10mg and Virgin Coconut Oil (VCO) in people with Dyslipidemias, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The present research will help to assess the effect of virgin coconut oil on cholesterol level and also will help to know whether virgin coconut oil can reduce the risk of heart diseases or not. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Dyslipidemias
What is being tested?: Atorvastatin 10mg and Virgin Coconut Oil (VCO)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteIndia
Study dates: 22 May 2019to 31 Dec 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with dyslipidemia [diagnosis of dyslipidemia is made when either of the lipid abnormality is present: LDL-C >140mg/dl, HDL-C <40mg/dl, Triglyceride >150mg/dl according to diagnostic criteria of dyslipidemia ]
Patients aged 18-65 years, of either sex.
Treatment-naive patients or patients who had not taken any treatment for at least 2 weeks before inclusion.

Who cannot join

History of any cardiovascular diseases, stroke, diabetes, malignancy, musculoskeletal or hepatic diseases
History of hypersensitivity to statins or coconut oil
Patients who are already under treatment for the presenting conditions.
Patients with drug/alcohol abuse.
Pregnant and nursing women.

Trial locations and contacts

1 site in 1 country.

India1 site

AIIMS, Bhubaneswar
Bhubaneswar, Odisha, 751019

Other trials in India

About this study

Official title: Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia: A Randomized, add-on, Placebo-controlled Clinical Trial

The present research will help to assess the effect of virgin coconut oil on cholesterol level and also will help to know whether virgin coconut oil can reduce the risk of heart diseases or not.

Read the detailed description

Dyslipidemia is a well-established risk factor for cardiovascular (CV) diseases. Lipid abnormalities, including high levels of low-density lipoprotein cholesterol (LDL-C), elevated triglycerides and low levels of high-density lipoprotein cholesterol (HDL-C), are independent predictors of CV disease. The National Cholesterol Education Program Adult Treatment Panel III (ATP III) guideline and the American College of Cardiology (ACC) and American Heart Association (AHA) guideline recommend the use of statins for primary prevention based on a patient's cardiovascular risk profile and low-density lipoprotein cholesterol (LDL-C) level. However, statin therapy may be insufficient for patients with mixed dyslipidemia, especially those with metabolic syndromes. While the addition of niacin, fibrate or ezetimibe may be useful in this setting, the combination therapy may lead to more adverse drug reactions.

Virgin Coconut Oil (VCO), a nutraceutical, is an oil obtained from the fresh, mature kernel of the coconut by mechanical or natural means, with or without the use of heat and without undergoing chemical refining and it contains a considerable amount of medium-chain fatty acids similar to those in mother's milk. The beneficial effects of VCO in the reduction of cardiovascular risk have been proved from previous animal and clinical studies. The previous study demonstrated the potential beneficiary effect of VCO in lowering lipid levels in serum and LDL oxidation by physiological oxidants and this property of VCO was attributed to the biologically active polyphenol components present in the oil. It has been also demonstrated the hypolipidemic effect of VCO through activation of lipoprotein lipase, lecithin cholesterol acyltransferase and enhanced formation of bile acids. It was found that isolated polyphenols from VCO can prevent cadmium-induced lipid abnormalities and cardiovascular risk ratios by improving antioxidant defence systems. VCO may improve cardiovascular and hepatic complications in obesity. The findings from another study suggest a beneficial eﬀect of VCO on lipid profile, renal status, hepatic antioxidant defence system, and cardiovascular risk indices in rats. It has been observed that VCO increased HDL-C level in patients with coronary artery disease (CAD). In a randomized crossover trial, it was found that daily consumption of VCO in young healthy adults significantly increased high-density lipoprotein cholesterol without any safety issues.

Our literature search revealed that to date, no clinical trial evaluated the potential of VCO as an add-on hypolipidemic agent in patients suffering from dyslipidemia. So, the present clinical trial has been designed to evaluate the effect of VCO on cardiometabolic parameters as an add-on with statins in patients with dyslipidemia.

Conditions: Dyslipidemias
Being tested: Atorvastatin 10mg, Virgin Coconut Oil (VCO), Placebo
Keywords: Cardiometabolic parameters, Virgin coconut oil, Serum lipoprotein, Lipid peroxidation, Atorvastatin
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atorvastatin 10mgDrug
Atorvastatin 10 mg per day
Virgin Coconut Oil (VCO)Dietary supplement
Capsule VCO (1000 mg/day)
PlaceboOther
Placebo capsule - 1 capsule per day

Study groups in NCT03906539
Study group	Role	What they receive
Control Group	Placebo comparator	The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule. Receives: Drug: Atorvastatin 10mg; Other: Placebo
VCO Group	Experimental	The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day). Receives: Drug: Atorvastatin 10mg; Dietary Supplement: Virgin Coconut Oil (VCO)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in serum High Density Lipoprotein (HDL)
Will be measured by autoanalyser
Measured: Baseline and 8 weeks

Secondary outcomes (10)

Change in serum Lipoprotein (a)
Will be measured by ELISA
Measured: Baseline and 8 weeks
Change in Atherogenic index
Ratio of LDL cholesterol and HDL cholesterol
Measured: Baseline and 8 weeks
Change in Coronary risk index
Ratio of total cholesterol and HDL cholesterol
Measured: Baseline and 8 weeks
Change in Cardiovascular risk index
Ratio of triglyceride and HDL cholesterol
Measured: Baseline and 8 weeks
Change in visceral fat
Will be analysed by by digital body fat analyser
Measured: Baseline and 8 weeks
Change in lipid peroxidation
Thiobarbituric acid reactive substances (TBARS) will be estimated by spectrofluorometric method
Measured: Baseline and 8 weeks
Change in serum Low Density Lipoprotein (LDL)
Will be measured by autoanalyser
Measured: Baseline and 8 weeks
Change in serum Very Low Density Lipoprotein (VLDL)
Will be measured by autoanalyser
Measured: Baseline and 8 weeks
Change in serum total cholesterol
Will be measured by autoanalyser
Measured: Baseline and 8 weeks
Change in serum triglyceride
Will be measured by autoanalyser
Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201931 Dec 2021

First posted8 Apr 2019
Study start22 May 2019
Primary completion30 Nov 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for DyslipidemiasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03906539
Sponsor's protocol ID: T/EMF/Pharma/18/23
Status last verified: Apr 2022
First submitted: 5 Apr 2019
Last updated: 6 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
PubMed 15364185
Gordon DJ, Probstfield JL, Garrison RJ, Neaton JD, Castelli WP, Knoke JD, Jacobs DR Jr, Bangdiwala S, Tyroler HA. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation. 1989 Jan;79(1):8-15. doi: 10.1161/01.cir.79.1.8.
PubMed 2642759
Sarwar N, Danesh J, Eiriksdottir G, Sigurdsson G, Wareham N, Bingham S, Boekholdt SM, Khaw KT, Gudnason V. Triglycerides and the risk of coronary heart disease: 10,158 incident cases among 262,525 participants in 29 Western prospective studies. Circulation. 2007 Jan 30;115(4):450-8. doi: 10.1161/CIRCULATIONAHA.106.637793. Epub 2006 Dec 26.
PubMed 17190864
Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007 Jul 18;298(3):309-16. doi: 10.1001/jama.298.3.309.
PubMed 17635891
Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13;110(2):227-39. doi: 10.1161/01.CIR.0000133317.49796.0E.
PubMed 15249516
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
PubMed 24222016
Famurewa AC, Ekeleme-Egedigwe CA, Nwali SC, Agbo NN, Obi JN, Ezechukwu GC. Dietary Supplementation with Virgin Coconut Oil Improves Lipid Profile and Hepatic Antioxidant Status and Has Potential Benefits on Cardiovascular Risk Indices in Normal Rats. J Diet Suppl. 2018 May 4;15(3):330-342. doi: 10.1080/19390211.2017.1346031. Epub 2017 Aug 17.
PubMed 28816548
Nevin KG, Rajamohan T. Beneficial effects of virgin coconut oil on lipid parameters and in vitro LDL oxidation. Clin Biochem. 2004 Sep;37(9):830-5. doi: 10.1016/j.clinbiochem.2004.04.010.
PubMed 15329324
Arunima S, Rajamohan T. Virgin coconut oil improves hepatic lipid metabolism in rats--compared with copra oil, olive oil and sunflower oil. Indian J Exp Biol. 2012 Nov;50(11):802-9.
PubMed 23305031
[Should the specialist examination be introduced? Thoughts of the Education Committee]. Ugeskr Laeger. 1969 Jan 23;131(4):170-1. No abstract available. Danish.
PubMed 5787998
Panchal SK, Carnahan S, Brown L. Coconut Products Improve Signs of Diet-Induced Metabolic Syndrome in Rats. Plant Foods Hum Nutr. 2017 Dec;72(4):418-424. doi: 10.1007/s11130-017-0643-0.
PubMed 29079969
Cardoso DA, Moreira AS, de Oliveira GM, Raggio Luiz R, Rosa G. A COCONUT EXTRA VIRGIN OIL-RICH DIET INCREASES HDL CHOLESTEROL AND DECREASES WAIST CIRCUMFERENCE AND BODY MASS IN CORONARY ARTERY DISEASE PATIENTS. Nutr Hosp. 2015 Nov 1;32(5):2144-52. doi: 10.3305/nh.2015.32.5.9642.
PubMed 26545671
Chinwong S, Chinwong D, Mangklabruks A. Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial. Evid Based Complement Alternat Med. 2017;2017:7251562. doi: 10.1155/2017/7251562. Epub 2017 Dec 14.
PubMed 29387131
Teramoto T, Sasaki J, Ueshima H, Egusa G, Kinoshita M, Shimamoto K, Daida H, Biro S, Hirobe K, Funahashi T, Yokote K, Yokode M; Japan Atherosclerosis Society (JAS) Committee for Epidemiology and Clinical Management of Atherosclerosis. Diagnostic criteria for dyslipidemia. Executive summary of Japan Atherosclerosis Society (JAS) guideline for diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese. J Atheroscler Thromb. 2007 Aug;14(4):155-8. doi: 10.5551/jat.e537. No abstract available.
PubMed 17827859
Ermakova GL, Abakumov EM, Martynova VA. [Immunological and microbiological parallels in pneumonia complicating leukemia]. Klin Med (Mosk). 1973 Feb;51(2):29-32. No abstract available. Russian.
PubMed 4700825

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia: A Randomized, add-on, Placebo-controlled Clinical Trial
ClinicalTrials.gov ID: NCT03906539
Acronym / sponsor ID: T/EMF/Pharma/18/23
Conditions: Dyslipidemias
Keywords: Cardiometabolic parameters, Virgin coconut oil, Serum lipoprotein, Lipid peroxidation, Atorvastatin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
Collaborators: Coconut Development Board, Government of India
Study start: 22 May 2019 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 8 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The present research will help to assess the effect of virgin coconut oil on cholesterol level and also will help to know whether virgin coconut oil can reduce the risk of heart diseases or not.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Control Group	Placebo comparator	Drug: Atorvastatin 10mg, Other: PlaceboThe patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.
VCO Group	Experimental	Drug: Atorvastatin 10mg, Dietary Supplement: Virgin Coconut Oil (VCO)The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with dyslipidemia [diagnosis of dyslipidemia is made when either of the lipid abnormality is present: LDL-C >140mg/dl, HDL-C <40mg/dl, Triglyceride >150mg/dl according to diagnostic criteria of dyslipidemia ]
Patients aged 18-65 years, of either sex.
Treatment-naive patients or patients who had not taken any treatment for at least 2 weeks before inclusion.

Key exclusion criteria (5 listed)

History of any cardiovascular diseases, stroke, diabetes, malignancy, musculoskeletal or hepatic diseases
History of hypersensitivity to statins or coconut oil
Patients who are already under treatment for the presenting conditions.
Patients with drug/alcohol abuse.
Pregnant and nursing women.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atorvastatin 10mgAtorvastatin 10 mg per day	Drug	Control Group, VCO Group
Virgin Coconut Oil (VCO)Capsule VCO (1000 mg/day)	Dietary supplement	VCO Group
PlaceboPlacebo capsule - 1 capsule per day	Other	Control Group

Primary outcome

Change in serum High Density Lipoprotein (HDL)
Time frame: Baseline and 8 weeks
Will be measured by autoanalyser

10 secondary outcomes

Change in serum Lipoprotein (a)
Time frame: Baseline and 8 weeks
Change in Atherogenic index
Time frame: Baseline and 8 weeks
Change in Coronary risk index
Time frame: Baseline and 8 weeks
Change in Cardiovascular risk index
Time frame: Baseline and 8 weeks
Change in visceral fat
Time frame: Baseline and 8 weeks
Change in lipid peroxidation
Time frame: Baseline and 8 weeks
Change in serum Low Density Lipoprotein (LDL)
Time frame: Baseline and 8 weeks
Change in serum Very Low Density Lipoprotein (VLDL)
Time frame: Baseline and 8 weeks
Change in serum total cholesterol
Time frame: Baseline and 8 weeks
Change in serum triglyceride
Time frame: Baseline and 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Results publication: PubMed 15364185Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
Results publication: PubMed 2642759Gordon DJ, Probstfield JL, Garrison RJ, Neaton JD, Castelli WP, Knoke JD, Jacobs DR Jr, Bangdiwala S, Tyroler HA. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation. 1989 Jan;79(1):8-15. doi: 10.1161/01.cir.79.1.8.
Results publication: PubMed 17190864Sarwar N, Danesh J, Eiriksdottir G, Sigurdsson G, Wareham N, Bingham S, Boekholdt SM, Khaw KT, Gudnason V. Triglycerides and the risk of coronary heart disease: 10,158 incident cases among 262,525 participants in 29 Western prospective studies. Circulation. 2007 Jan 30;115(4):450-8. doi: 10.1161/CIRCULATIONAHA.106.637793. Epub 2006 Dec 26.
Results publication: PubMed 17635891Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007 Jul 18;298(3):309-16. doi: 10.1001/jama.298.3.309.
Results publication: PubMed 15249516Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13;110(2):227-39. doi: 10.1161/01.CIR.0000133317.49796.0E.
Results publication: PubMed 24222016Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
Results publication: PubMed 28816548Famurewa AC, Ekeleme-Egedigwe CA, Nwali SC, Agbo NN, Obi JN, Ezechukwu GC. Dietary Supplementation with Virgin Coconut Oil Improves Lipid Profile and Hepatic Antioxidant Status and Has Potential Benefits on Cardiovascular Risk Indices in Normal Rats. J Diet Suppl. 2018 May 4;15(3):330-342. doi: 10.1080/19390211.2017.1346031. Epub 2017 Aug 17.
Results publication: PubMed 15329324Nevin KG, Rajamohan T. Beneficial effects of virgin coconut oil on lipid parameters and in vitro LDL oxidation. Clin Biochem. 2004 Sep;37(9):830-5. doi: 10.1016/j.clinbiochem.2004.04.010.
Results publication: PubMed 23305031Arunima S, Rajamohan T. Virgin coconut oil improves hepatic lipid metabolism in rats--compared with copra oil, olive oil and sunflower oil. Indian J Exp Biol. 2012 Nov;50(11):802-9.
Results publication: PubMed 5787998[Should the specialist examination be introduced? Thoughts of the Education Committee]. Ugeskr Laeger. 1969 Jan 23;131(4):170-1. No abstract available. Danish.
Results publication: PubMed 29079969Panchal SK, Carnahan S, Brown L. Coconut Products Improve Signs of Diet-Induced Metabolic Syndrome in Rats. Plant Foods Hum Nutr. 2017 Dec;72(4):418-424. doi: 10.1007/s11130-017-0643-0.
Results publication: PubMed 26545671Cardoso DA, Moreira AS, de Oliveira GM, Raggio Luiz R, Rosa G. A COCONUT EXTRA VIRGIN OIL-RICH DIET INCREASES HDL CHOLESTEROL AND DECREASES WAIST CIRCUMFERENCE AND BODY MASS IN CORONARY ARTERY DISEASE PATIENTS. Nutr Hosp. 2015 Nov 1;32(5):2144-52. doi: 10.3305/nh.2015.32.5.9642.
Individual participant dataSharing planned: No

Related trials for Dyslipidemias

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin 10mg and Virgin Coconut Oil (VCO) in people with Dyslipidemias, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum High Density Lipoprotein (HDL) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03906539, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.